Summary

Eligibility
for people ages 12-75 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

The objective of this study is to assess the efficacy and safety of upadacitinib for the treatment of adolescent and adult participants with moderate to severe Atopic Dermatitis (AD) who are candidates for systemic therapy.

Official Title

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

Keywords

Atopic Dermatitis Upadacitinib Dermatitis, Atopic Dermatitis Eczema

Eligibility

You can join if…

Open to people ages 12-75

  • Body weight of >= 40kg at Baseline Visit for participants between >= 12 and <18 years of age
  • Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline Visit
  • Active moderate to severe AD defined by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), Body surface area (BSA), and pruritus
  • Candidate for systemic therapy or have recently required systemic therapy for AD
  • Documented history of inadequate response to topical corticosteroids (TCS) or topical calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months before Baseline Visit

You CAN'T join if...

  • Prior exposure to any Janus kinase (JAK) inhibitor
  • Unable or unwilling to discontinue current atopic dermatitis (AD) treatments prior to the study
  • Requirement of prohibited medications during the study
  • Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions
  • Female subject who is pregnant, breastfeeding, or considering pregnancy during the study

Locations

  • UC Davis /ID# 203622 in progress, not accepting new patients
    Sacramento California 95817 United States
  • Care Access Research /ID# 200940 in progress, not accepting new patients
    Walnut Creek California 94598-2488 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. Sign up for this study
ID
NCT03569293
Phase
Phase 3
Study Type
Interventional
Last Updated